Varying Willingness to Pay Based on Severity of Illness: Impact on Health Technology Assessment Outcomes of Inpatient and Outpatient Drug Therapies in The Netherlands

Abstract

Objectives: Since 2015, Zorginstituut Nederland (ZIN) has linked disease severity ranges of 0.10 to 0.40, 0.41 to 0.70, and 0.71 to 1.00 with willingness-to-pay (WTP) reference values of V20 000, V50 000, and V80 000 per quality-adjusted life year gained, respectively. We sought to review whether these changes have affected ZIN health technology assessment (HTA) outcomes for specialist and outpatient drugs.Methods: ZIN recommendations for specialist and outpatient drugs published between January 1, 2012, and December 31, 2020, that included a pharmacoeconomic report were reviewed. Data were extracted on disease severity, proportional shortfall calculation, reported WTP reference value, outcomes related to the cost-effectiveness of the product, budget impact, and ZIN's recommendation including rationale for their advice.Results: A total of 51 HTAs were included. Of the 20 HTAs published before June 2015, a total of 9 received positive recommendations, 7 were conditionally reimbursed, and 4 received negative recommendations. None reported WTP reference values. Of the 31 evaluations published after June 2015, a total of 4 products received positive recommendations, 1 was conditionally approved, and 26 received negative recommendations initially. Most products (65%) reported disease severity to be .0.70.Conclusions: Since 2015, most products have fallen within the highest category of disease severity. Although pre-2015 outcomes were varied, post-2015 products overwhelmingly received negative recommendations, and the proportion of products for which price negotiations were recommended has increased. These differences in outcomes may result from the introduction of an explicit WTP reference value, whether or not in combination with the severity-adjusted ranges, but may also reflect other national policy changes in 2015.

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“…Some countries have published explicit CET ranges, but the values vary considerably from country to country [ 47 ]. To promote the health technology assessment on healthcare interventions, the Netherlands considers disease severity when setting a WTP threshold, indicating the threshold ranges from €10,000 per QALY for diseases with a severity of 0.10 to €80,000 per QALY for diseases with a severity of 1.0 [ 48 ]. This approach resulted in much higher WTP thresholds for life-threatening diseases, with breast cancer at an estimated severity of 0.86 [ 48 ].…”

“…To promote the health technology assessment on healthcare interventions, the Netherlands considers disease severity when setting a WTP threshold, indicating the threshold ranges from €10,000 per QALY for diseases with a severity of 0.10 to €80,000 per QALY for diseases with a severity of 1.0 [ 48 ]. This approach resulted in much higher WTP thresholds for life-threatening diseases, with breast cancer at an estimated severity of 0.86 [ 48 ]. In this review, Yang et al [ 27 ] addressed this challenge by investigating the cost-effectiveness outcome and uncertainty around some key parameters, such as cancer incidence, attendance rate, the compliance rate for diagnosis, and detection of the tumour at the early stage through threshold analysis, and Sun et al (2022) adopted a one GDP threshold in their baseline analysis to mitigate the uncertainty around the WTP threshold [ 25 ].…”

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“…In a broader view of generalisability, one also needs to consider the limit of what society is willing to accept for a QALY lost. In the Netherlands, the WTP is generally considered to be €50 000/QALY gained, although not officially stated or documented 72 84. It is important to note that whether or not the WTP value is the same as the WTA value is under debate.…”

“…In order to assess cost-effectiveness, the ICER has to be compared with a willingness-to-accept (WTA) threshold. Due to the fact that the burden of disease (ie, proportional shortfall) was between 0.4 and 0.7 (ratio of QALYs gained to QALYs lost; range 0–1), a corresponding WTA threshold of €50,000/QALY lost was considered justifiable 72…”

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“…The aim was to reflect the judgement of society's willingness to pay more for patients with conditions of greater need. Three distinct ranges of disease severity were developed and assigned willingness to pay reference values ranging from of EUR 20,000 to EUR 80,000 per QALY gained, based on the severity category in which the disease falls [53].…”